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替尔泊肽在亚洲和非亚洲2型糖尿病患者中的疗效和安全性比较:一项系统评价和荟萃分析

Comparative Efficacy and Safety of Tirzepatide in Asians and Non-Asians with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis.

作者信息

Cui Yuying, Yao Jinming, Qiu Xiaodong, Guo Congcong, Kong Degang, Dong Jianjun, Liao Lin

机构信息

First Clinical Medical College, Shandong University of Traditional Chinese Medicine, Shandong Provincial Qianfoshan Hospital, Shandong Key Laboratory of Rheumatic Disease and Translational medicine, Shandong Institute of Nephrology, Jinan, China.

Department of Endocrinology and Metabology, The First affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Shandong Key Laboratory of Rheumatic Disease and Translational medicine, Shandong Institute of Nephrology, Jinan, China.

出版信息

Diabetes Ther. 2024 Apr;15(4):781-799. doi: 10.1007/s13300-024-01540-7. Epub 2024 Feb 24.

Abstract

INTRODUCTION

Tirzepatide is a novel hypoglycemic agent for type 2 diabetes mellitus (T2DM). However, the pathophysiology of T2DM in Asians is different from that in non-Asians, and there is no evidence to explain the differences in the efficacy and safety of tirzepatide between different races.

METHODS

A literature search was conducted in China National Knowledge Infrastructure (CNKI), PubMed, Cochrane Library, Clinical Trials.gov, and Embase databases for clinical studies of tirzepatide for T2DM. The data extraction process was done independently by two authors. All analyses were performed using STATA 14.0 software and Review Manager 5.3 software.

RESULTS

A total of 2118 patients with T2DM from 6 studies were involved, with doses of tirzepatide ranging from 5 to 15 mg administered subcutaneously once weekly. The results showed that compared with control/placebo, tirzepatide was more effective in decreasing fasting blood glucose (FBG) in non-Asians than in Asians, and 10 mg rather than 15 mg was the optimal dose to decrease FBG. Similarly, non-Asians were more effective than Asians in improving glycated hemoglobin (HbA1c). Asians were significantly more effective than non-Asians in reducing body weight and ≥ 5% weight loss. In terms of adverse events, the incidence of gastrointestinal adverse events was higher in Asians than in non-Asians at the same dose, while the incidence of metabolic and nutrition disorders was higher in non-Asians than in Asians.

CONCLUSION

Tirzepatide is a novel agent for the treatment of diabetes and has different efficacy in Asians and non-Asians. Asians were more likely to experience weight loss and gastrointestinal adverse events, whereas non-Asians were more likely to have better glycemic control and more metabolic and nutritional disorders.

TRIAL REGISTRATION

PROSPERO registration no. CRD42023489588.

摘要

引言

替尔泊肽是一种用于治疗2型糖尿病(T2DM)的新型降糖药物。然而,亚洲人T2DM的病理生理学与非亚洲人不同,且尚无证据解释替尔泊肽在不同种族间疗效和安全性差异的原因。

方法

在中国知网(CNKI)、PubMed、Cochrane图书馆、ClinicalTrials.gov和Embase数据库中检索替尔泊肽治疗T2DM的临床研究。数据提取过程由两位作者独立完成。所有分析均使用STATA 14.0软件和Review Manager 5.3软件进行。

结果

6项研究共纳入2118例T2DM患者,替尔泊肽剂量为5至15mg,每周皮下注射一次。结果显示,与对照组/安慰剂相比,替尔泊肽在降低非亚洲人的空腹血糖(FBG)方面比亚洲人更有效,降低FBG的最佳剂量为10mg而非15mg。同样,非亚洲人在改善糖化血红蛋白(HbA1c)方面比亚洲人更有效。亚洲人在减轻体重和≥5%体重减轻方面比非亚洲人显著更有效。在不良事件方面,相同剂量下亚洲人的胃肠道不良事件发生率高于非亚洲人,而非亚洲人的代谢和营养障碍发生率高于亚洲人。

结论

替尔泊肽是一种新型糖尿病治疗药物,在亚洲人和非亚洲人中疗效不同。亚洲人更易出现体重减轻和胃肠道不良事件,而非亚洲人血糖控制更佳,且更易出现代谢和营养障碍。

试验注册

PROSPERO注册号CRD42023489588。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b2ae/10951192/690514a2edcc/13300_2024_1540_Fig1_HTML.jpg

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